Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Difference in Dynamic Gait Index (DGI)
研究概览
简要总结
The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control.
详细描述
The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control. Chronic imbalance leads to significant problems. This study is designed to evaluate a device which can potentially improve the balance of these patients.
The participant will be asked to come to Washington University on three occasions for approximately 2 hours. Between visits, they will be asked to use the device daily (intervention condition) or to not use the device (control condition) for a prescribed period of time doing different activities. They will be provided written instructions from a physical therapist that will be determined by their individual ability. The activities will be typical exercises that are given to people with balance disorders. After 6 weeks of home use, participants will return for the second visit, and will repeat the evaluation. They will then return home and complete the either the control or intervention condition (which was not done the first time) in a crossover design.
On their first visit (week 0; baseline) participants will be asked to complete the same kind of tests that evaluated the function of their balance system at the time of their diagnosis. They will have their eye movements recorded using goggles and an infra-red camera while the prosthesis is in place and providing vibration feedback. Computerized Dynamic Posturography (CDP) testing will require them to stand on a platform and perform tests (20 seconds each) with their eyes open or closed, with the platform moving or still, and/or with the visual surround either stable or moving. They will be fitted with a safety harness that will keep them from falling. Next the investigators will evaluate their ability to perform movement tasks while walking (walking down the hall, walking down the hall avoiding objects, changing speeds while walking, going up and down stairs etc). They will walk a 25-foot distance at a comfortable gait speed, and again at a maximum gait speed. Lastly, they will be asked to fill out questionnaires.
On their second and last visit, they will repeat the evaluations that were performed during the first visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory
- •Chronic imbalance for at least 1 year
- •Have reached a functional performance plateau with respect to balance performance
- •Have a DGI score of <19
- •Fall below age and gender matched normative data for gait speed
排除标准
- •Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.
- •Women who are pregnant (women will self-report possible pregnancy).
结局指标
主要结局
Difference in Dynamic Gait Index (DGI)
时间窗: Week 0 (baseline)
This outcome compared the Dynamic Gait Index score when the BALCAP prosthesis was worn vs. when it was not worn at baseline in order to evaluate if there is an assistive benefit to wearing the device. The Dynamic Gait Index (DGI) is a clinical tool to assess gait, balance, and fall risk using various walking tasks. The range of scores is 0 to 24. A higher score is better. All participants performed this test at baseline both wearing the BALCAP and not wearing the BALCAP. This test does not measure a change in DGI score over time but compares the results of the test while wearing the BALCAP vs. not wearing the BALCAP during the same evaluation period (baseline).
次要结局
- Difference in Gait Speed(Week 0 (baseline))
- Change in Computerized Dynamic Posturography: Equilibrium Score(Before and after 6 weeks of either the intervention or the control condition)
- Change in Dizziness Handicap Inventory Score(Before and after 6 weeks of either the intervention or the control condition)
- Change in Activities-specific Balance Confidence (ABC) Scale(Before and after 6 weeks of either the intervention or the control condition)